1.Quality evaluation of adverse drug reaction reports in clinical departments based on game theory combinatorial weighting-TOPSIS-rank-sum ratio method
Haikun WANG ; Zichuang MA ; Na WU ; Aizong SHEN ; Xiangdong JIANG ; Maomao ZHANG ; Dan SU
China Pharmacy 2025;36(23):2969-2973
OBJECTIVE To comprehensively evaluate the quality of adverse drug reaction (ADR) reports in clinical departments or ward (hereinafter referred to as “department”) based on game theory combinatorial weighting-technique for order preference by similarity to ideal solution (TOPSIS)-rank-sum ratio (RSR) method, providing a reference for the further standardization of ADR reporting. METHODS Based on relevant documents and scoring criteria, the ADR report quality evaluation standards previously developed by our team were modified. Using game theory principles, the fusion of subjective and objective weights for each indicator was determined. A game theory combinatorial weighting-TOPSIS-RSR model was developed to evaluate and categorize the quality of raw ADR reports submitted by departments to the pharmacy department at Bozhou Hospital of Anhui Medical University. RESULTS A total of 222 ADR reports from 23 departments were included. The game theory combinatorial weighting method identifies weak points in management, such as ADR symptoms and signs, the description of underlying diseases, timing of ADR, by optimizing the weightings of the indicators. The TOPSIS-RSR method calculates that the mean relative closeness of the departments was 0.401 7, indicating that the overall report quality ranged from moderate to substandard. 20095) Three departments, including neurosurgery, demonstrated medium reporting quality [estinate closeness (Ĉ)i ≥0.506], while two departments, such as the respiratory department,were rated as unqualified (Ĉi<0.278). The remaining departments were all deemed qualified (0.278≤ Ĉi<0.506). CONCLUSIONS The developed game theory combinatorial weighting-TOPSIS-RSR method provides an effective approach for the quality evaluation of ADR reports, which not only balances subjective and objective weights but also facilitates comparisons among different departments. There is still room for improvement in the ADR report quality at the hospital.
2.Asian consensus on normothermic intraperitoneal and systemic treatment for gastric cancer with peritoneal metastasis
Zhenggang ZHU ; Kitayama Joji ; Hyung-Ho Kim ; Jimmy Bok-Yan So ; Hui CAO ; Lin CHEN ; Xiangdong CHENG ; Jiankun HU ; Imano Motohiro ; Ishigami Hironori ; Ye Seob Jee ; Jong-Han Kim ; Yasuhiro Kodera ; Han LIANG ; Xiaowen LIU ; Sheng LU ; Yiping MOU ; Mingming NIE ; Won Jun Seo ; Yanong WANG ; Dan WU ; Zekuan XU ; Yamaguchi Hironori ; Chao YAN ; Zhongyin YANG ; Kai YIN ; Yonemura Yutaka ; Wei-Peng Yong ; Jiren YU ; Jun ZHANG ; Asian Gastric Cancer NIPS Treatment Collaborative Group ; Shanghai Anticancer Association, Committee of Peritoneal Tumor
Journal of Surgery Concepts & Practice 2025;30(4):277-294
Gastric cancer with peritoneal metastasis (GCPM) is a common and lethal manifestation of advanced gastric cancer, with a median survival of only 5-11 months. This consensus was developed by 30 experts from Asia (China, Japan, Korea, and Singapore) using the Delphi method and the GRADE evidence grading system. A total of 29 statements were formulated, covering the diagnosis and assessment of GCPM, indications for laparoscopic exploration and NIPS (normothermic intraperitoneal and systemic treatment), treatment regimens, prevention and management of complications, criteria for conversion surgery, and postoperative intraperitoneal therapy. The consensus aims to standardize clinical practice and improve the prognosis of patients with GCPM.
3.Study on the quality evaluation of Faeces Bombycis based on HPLC fingerprint and content determination
Miaoli WU ; Yunjing QIU ; Han LIN ; Xiaolin LIU ; Zhenyu LI ; Lin ZHOU ; Xiangdong CHEN ; Dongmei SUN
International Journal of Traditional Chinese Medicine 2025;47(7):970-977
Objective:To establish fingerprints of Faeces Bombycis and simultaneously determine the content of four amino acids; To evaluate the quality of Faeces Bombycis from different regions. The fingerprint of Faeces Bombycis was established and the contents of 4 amino acids were determined.Methods:Kromasil 100-5 C18 (4.6 mm×250 mm, 5 μm) column was used for phenyl isothiocyanate (PITC) pre-column derivation-high performance liquid chromatography with acetonitrile-0.1 mol/L sodium acetate solution (pH adjusted to 6.5 with acetic acid) (7:93) mixed solution, and acetonitrile-water (4:1) mixed solution were mobile phase for gradient elution. The flow rate was 1.0 ml/min; the column temperature was 35 ℃; the detection wavelength was 254 nm; the injection amount was 5 μl. The fingerprints of 17 batches of Faeces Bombycis were established, the common peaks were identified by comparison of reference materials, and the similarity evaluation and principal component analysis (PCA) were carried out. The contents of glycine, alanine, proline and phenylalanine were determined simultaneously.Results:A total of 12 common peaks were identified from the fingerprints of Faeces Bombycis, and 12 amino acids were identified. The similarity of 17 batches of samples was greater than 0.95. PCA analysis showed that the regional difference of the quality of Faeces Bombycis was not significant. Faeces Bombycis produced in Qujing city in Yunnan Province had the highest total contents of 4 amino acids.Conclusion:The method has good repeatability and can provide reference for the quality evaluation and standard improvement of Faeces Bombycis.
4.Inhibitory effect of IL-27 on the overactivation of microglia
Lingxi WU ; Yixuan DU ; Xiangdong GAO
Journal of China Pharmaceutical University 2024;55(6):801-808
Neuroinflammation mediated by microglia is essential for the occurrence and development of Alzheimer’s disease (AD). Through the analysis of the GEO database, it was found that IL-27 expression decreased in both the cerebral cortex and hippocampus of AD patients. In this study, the AD cell model of BV-2 cells injured by Aβ1-42, the inflammatory cell model of BV-2 cells damaged by LPS, and the inflammatory animal model were established and the effects of IL-27 after its administration in the above models in regulating microglial phenotype and neuroinflammation were evaluated. In the animal models, the number of Iba1+ microglia in the hippocampus was detected by immunohistochemistry, the expression of pro-inflammatory factors such as TNF-α, IL-1β and IL-6 was detected by qPCR, ELISA and Western blot, and the expression of M1/M2 phenotypic markers in microglia was detected by qPCR. To further explore the action mechanism of IL-27, Western blot was used to detect the expression levels of NF-κB, p-NF-κB, IκBα and p-IκBα in microglia after administration of IL-27 and Aβ1-42. The results showed that IL-27 alleviated the abnormal activation of microglia induced by lipopolysaccharide (LPS), decreased the expression of pro-inflammatory factors such as TNF- α, IL-1β and IL-6, transformed microglia induced by LPS or Aβ1-42 from neurotoxic M1 to neuroprotective M2, and improved the abnormal phosphorylation of NF-κB and IκBα induced by Aβ1-42. The research suggested that IL-27 can regulate the M1/M2 polarization of microglia induced by Aβ1-42 or LPS, and alleviate neuroinflammation.
5.Evaluation of short-term effects on 3D printing patient-matched artificial vertebral body in clinical research and application
Xiaokang LI ; Lei SHI ; Xiangdong LI ; Hai HUANG ; Qi WU ; Xiaodong TANG ; Zheng GUO
Chinese Journal of Orthopaedics 2024;44(6):354-361
Objective:To evaluate the short-term efficacy and safety of 3D printing patient-matched artificial vertebral body in clinical research and application.Methods:A total of 12 patients with spinal tumors were enrolled 7 males (58.33%) and 5 females (41.67%), aged from 18 to 65 years old in The First Affiliated Hospital of Air Force military Medical University (hereinafter referred to as Xijing Hospital) and Peking University people's Hospital from September 2021 to July 2022. The spinal vertebra defect were restored by using 3D printing patient-matched artificial vertebral body after tumor resection. All patients who accepted TES and 3D printing patient-matched artificial vertebral body implantation were included according to the inclusion and exclusion criteria. The bone interface fusion was evaluated by the imaging fusion criteria of Brantigan and Steffee at 3 and 6 months after operation, the curative effect was evaluated by comparing Japanese Orthopaedic Association (JOA) score at 3 and 6 months after operation, visual analogue scale (VAS) 3 months after operation and intervertebral height at 3 and 6 months after operation with those before operation, and the safety was evaluated by adverse event recording.Results:All 12 patients completed the operation successfully, and the operation sites were thoracic vertebrae in 6 cases (50%), thoracolumbar in 3 cases (25%) and lumbar vertebrae in 3 cases (25%). All patients were followed up. The mean follow-up time was 23.92±3.23 months (range, 19-29 months). No tumor recurrence or metastasis was observed during this period. All patients were followed up at 15 days, 3 months and 6 months after operation. During the 6-month follow-up, X ray results showed that interface of bone and the vertebral body were fused in all of the 12 patients, and the effective rate of fusion was 100%. The 95% confidence interval is calculated to be (75.6%-100%). Six months after operation, the improvement rate of JOA score was excellent in 10 cases, good in 1 case, poor in 1 case, and the excellent and good rate was 91.66%. The preoperative VAS score was 4.08 ±2.47, and during the 3-month follow-up, the VAS score was improved to 1.83 ±1.59. Compared with the preoperative VAS score, the difference was statistically significant ( t=2.635, P=0.023). The intervertebral height before operation, 15 days after operation, 3 months after operation and 6 months after operation were 32.75 (25.94, 68.20), 41.09 (30.55, 70.20), 40.70 (30.23, 67.83) and 40.74 (30.23, 67.08), respectively, and there was no statistically significant difference (χ 2=0.768, P=0.857). No implant-related adverse events occurred after operation. Conclusion:The 3D printing patient-matched artificial vertebral body used in this study has satisfactory short-term efficacy and safety in the reconstruction of spinal stability after spinal tumor resection.
6.Expression of Serum Vaspin and SFRP5 in Children with Idiopathic Nanosomia and Their Diagnostic Value
Yingshuang WU ; Xiangdong XUE ; Zhihui DU ; Lihong WANG ; Yuanbo CHENG ; Xiaoqing NIU ; Dawei WANG
Journal of Modern Laboratory Medicine 2024;39(1):95-99
Objective To explore the expression level of visceral adipose tissue-derived serine protease inhibitor(Vaspin)and secreted frizzled-related protein5(SFRP5)in the serum of children with idiopathic short stature(ISS)and its diagnostic value.Methods 70 children with ISS diagnosed in the First Hospital of Zhangjiakou from December 2021 to February 2023 were selected as the disease group,while 72 healthy volunteer children who underwent physical examination were collected as the control group.Immunoluminescence was applied to detect the expression level of VASPIN,Enzyme-linked immunosorbent assay(ELISA)was applied to detect the expression level of SFRP5 the clinical data of children in two groups were analyzed.Receiver operating characteristic(ROC)curve was applied to analyze the diagnostic value of serum Vaspin and SFRP5 for ISS,multivariate Logistic regression was used to analyze the influencing factors of ISS.Results Compared with the control group,the serum Vaspin level in the disease group was obviously increased(2.89±0.92 ng/ml vs 1.81±0.42 ng/ml),while the SFRP5 level was obviously reduced(10.22±2.84 pg/ml vs 13.21±3.53 pg/ml),the differences were statistically significant(t=9.040,5.552,all P<0.05).The weight,height,body mass index(BMI)and proportion of sexual development stage II~V of children in the disease group were obviously lower than those in the control group,and the differences were statistically significant(t=7.687,6.330,5.559,7.024,all P<0.05).The area under ROC curve showed that the AUC of Vaspin and SFRP5 and their combined detection in the diagnosis of ISS were 0.768,0.849 and 0.925,respectively,the combined diagnosis efficacy of Vaspin and SFRP5 was better than that of serum Vaspin and SFRP5 alone(Z =3.829,P<0.001;Z =2.141,P=0.032).Multivariate Logistic regression analysis showed that BMI(OR=0.508,95%CI:0.260~0.991),Vaspin(OR=3.458,95%CI:1.125~10.631)and SFRP5(OR=0.378,95%CI:0.153~0.935)were the influencing factors for ISS(all P<0.05).Conclusion The expression level of Vaspin in the serum of children with ISS is obviously increased,while the expression level of SFRP5 is obviously reduced.The two are influencing factors of ISS,and the combined detection of their expression levels has certain value in the diagnosis of ISS.
7.Efficacy and safety of neoadjuvant therapy with TCbHP regimen for human epidermal growth factor receptor 2-positive breast cancer
Donghong XU ; Xiangdong WU ; Shibo ZHANG ; Yongtao DU ; Chongzhu HU ; Enqing WANG
Cancer Research and Clinic 2024;36(8):590-593
Objective:To investigate the efficacy and safety of neoadjuvant therapy with trastuzumab and pertuzumab combined with taxane and platinum drugs (TCbHP) regimen for human epidermal growth factor receptor 2 (HER2)-positive breast cancer.Methods:A retrospective case series study was conducted. The clinical data of HER2-positive breast cancer patients who received neoadjuvant therapy with 21-day TCbHP regimen and completed subsequent surgery in 11 tertiary-level hospitals in Hebei Province from June 2019 to December 2021 were retrospectively analyzed, and the total pathological complete remission (tpCR) rate, the incidence of grade ≥3 adverse events, and the completion rate of the established regimen were statistically analyzed.Results:A total of 78 female patients were included and the median age [ M ( Q1, Q3)] was 54.0 years (48.5 years, 57.5 years). The tpCR rate was 64.1% (50/78). Subgroup analysis showed that the tpCR rate in the HER2 immunohistochemistry (IHC)+++ group was higher than that in the HER2 IHC++ and fluorescence in situ hybridization-positive group [68.6% (48/70) vs. 25.0% (2/8)], and the difference was statistically significant ( χ2 = 4.18, P = 0.041); the tpCR rate in the hormone-receptor negative group was higher than that in the hormone-receptor positive group [81.8% (27/33) vs. 51.1% (23/45)], and the difference was statistically significant ( χ2 = 7.80, P = 0.005); the tpCR rate in the albumin-bound paclitaxel group was higher than that in the docetaxel group [72.3% (34/47) vs. 48.3% (14/29)], and the difference was statistically significant ( χ2 = 4.46, P = 0.035). The incidence of ≥ grade 3 adverse reactions was 12.8% (10/78) in 78 patients, and the completion rate of the established regimen was 92.3% (72/78). Conclusions:Neoadjuvant therapy with TCbHP regimen for HER2-positive breast cancer shows a definite efficacy, good safety and tolerance.
8.Progress of breast cancer with low expression of human epidermal growth factor receptor 2
Cancer Research and Clinic 2024;36(8):630-633
Human epidermal growth factor receptor 2 (HER2) is an important therapeutic target for breast cancer in recent years. The emergence of targeted drugs represented as trastuzumab has drastically improved the prognosis of HER2-positive breast cancer patients. Antibody-drug conjugates (ADC) such as trastuzumab deruxtecan (T-DXd) have shown the obvious therapeutic efficacies in breast cancer with HER2 low expression recently, which has become a research hotpot. With the deepening of the research, new views of the detection of HER2 and the molecular subtypes of breast cancer are proposed, besides, the concept of ultra-low HER2 expression is also proposed by some scholars. Several studies have explored the application of ADC and new treatments in HER2 low expression breast cancer. This paper reviews the definition, the detection and determination, clinicopathologic characteristics and treatment progress of breast cancer with HER2 low expression.
9.Rapid construction of rPRV-ΔTK/EGFP variant strain using CRISPR/Cas9 sys-tem
Zaijiao YE ; Chuan ZENG ; Jun GU ; Peixia WANG ; Jinyan SHEN ; Deping SONG ; Dongyan HUANG ; Xiangdong WU ; Houjun HE ; Yuxin TANG ; Yu YE
Chinese Journal of Veterinary Science 2024;44(6):1223-1228
Pseudorabies virus(PRV)is the etiological agent of pseudorabies in pigs,which is char-acterized by dyspnea,reproductive disorders,and neurological diseases,and it spreads widely a-round the world.Since 2011,the newly emerged PRV variants have resulted in poor immunity pro-tection of traditional vaccine strains,and the original method of vaccine strain preparation is time-consuming and labor-intensive.Therefore,it is urgently needed to develop an efficient screening method of the vaccine strain at present.Using CRISPR/Cas9 gene editing technology in this study,two single guide RNAs(sgRNA)were designed targeting the virulence gene TK of PRV variant strain CH/JX/2016,and then the enhanced green fluorescent protein the reporter(EGFP)gene was inserted at the TK locus by a homologous repair plasmid.After multiple rounds of plaque puri-fication,the rPRV-ΔTK/EGFP strain was obtained.The results showed the cleavage efficiency of the two sgRNAs was extremely high.The preparation of rPRV-ΔTK/EGFP strain was succeed af-ter only three rounds of purification,and the EGFP expressed normally.The CRISPR/Cas9 system can edit the PRV gene simply,rapidly,and efficiently,and exhibits great potential in the construction of vaccine candidate strains.Meanwhile,the rescued rPRV-ΔTK/EGFP strain not only could be used as a tracer strain in PRV variant infection progresses,but also for subsequent antivi-ral drug screening.
10.Predictive value of left ventricular global longitudinal peak strain for the prognosis of septic patients
Lingyun ZUO ; Wenliang SONG ; Yongjun LIU ; Jianfeng WU ; Xiangdong GUAN ; Xiang SI
Chinese Critical Care Medicine 2024;36(4):353-357
Objective:To investigate the predictive value of left ventricular global longitudinal peak strain (GLPS) for the prognosis of septic patients.Methods:A prospective cohort study was conducted. Patients diagnosed with sepsis and admitted to the intensive care unit (ICU) of the First Affiliated Hospital, Sun Yat-sen University from December 2018 to November 2019 were enrolled. The patient characteristics, cardiac ultrasound parameters [left ventricular ejection fraction (LVEF), right ventricular ejection fraction (RVEF), four-dimensional ejection fraction (4DEF), GLPS] and cardiac biomarkers [N-terminal pro-brain natriuretic peptide (NT-proBNP), cardiac troponin T (cTnT)] within 24 hours of ICU admission, organ support therapies, severity of illness, and prognostic indicators were documented. The differences in clinical parameters between patients with varying outcomes during ICU hospitalization were assessed. Pearson correlation analysis was employed to explore the correlation between GLPS and other cardiac systolic parameters, as well as the associations between various cardiac systolic parameters and sequential organ failure assessment (SOFA) score. Receiver operator characteristic curve (ROC curve) was drawn to analyze the predictive capacity of cardiac ultrasound parameters and cardiac biomarkers for death during ICU hospitalization in septic patients.Results:A total of 50 septic patients were enrolled, with 40 surviving and 10 dying during ICU hospitalization, resulting in a mortality of 20.0%. All patients in the death group were male. Compared with the survival group, the patients in the death group were older, had a higher prevalence of diabetes mellitus, and received continuous renal replacement therapy (CRRT) more frequently, additionally, they exhibited more severe illness and had longer length of ICU stay. The levels of GLPS and cTnT in the death group were significantly elevated as compared with the survival group [GLPS: -7.1% (-8.5%, -7.0%) vs. -12.1% (-15.5%, -10.4%), cTnT (μg/L): 0.07 (0.05, 0.08) vs. 0.03 (0.02, 0.13), both P < 0.05]. However, no statistically significant difference was found in other cardiac ultrasound parameters or cardiac biomarkers between the two groups. Pearson correlation analysis revealed a negative correlation between GLPS and LVEF ( r = -0.377, P = 0.014) and 4DEF ( r = -0.697, P = 0.000), while no correlation was found with RVEF ( r = -0.451, P = 0.069). GLPS demonstrated a positive correlation with SOFA score ( r = 0.306, P = 0.033), while LVEF ( r = 0.112, P = 0.481), RVEF ( r = -0.134, P = 0.595), and 4DEF ( r = -0.251, P = 0.259) showed no significant correlation with SOFA score. ROC curve analysis indicated that the area under the ROC curve (AUC) of GLPS for predicting death during ICU hospitalization in septic patients was higher than other cardiac systolic parameters, including LVEF, RVEF, and 4DEF, as well as cardiac biomarkers NT-proBNP and cTnT (0.737 vs. 0.628, 0.556, 0.659, 0.580 and 0.724). With an optimal cut-off value of -14.9% for GLPS, the sensitivity and negative predictive value reached to 100%. Conclusion:GLPS < -14.9% within 24 hours of ICU admission in septic patients indicated a reduced risk of death risk during ICU hospitalization, while also correlating with the severity of organ dysfunction in this patient population.

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